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Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00092976
First received: September 28, 2004
Last updated: December 19, 2007
Last verified: May 2006
History of Changes
  Purpose

The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.


Condition Intervention Phase
Hemophilia A
 Drug: ReFacto
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IV Study of the Safety and Efficacy of ReFacto® (Moroctocog Alfa, B-Domain Deleted Recombinant Factor VIII) in Subjects With Hemophilia A Undergoing Major Surgery Monitored Using the Chromogenic Substrate Assay at the Local Laboratory

Resource links provided by NLM:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To evaluate the safety and efficacy of ReFacto in subjects with Hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.

Secondary Outcome Measures:
  • To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory

Estimated Enrollment: 15
Study Start Date: February 2003
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 6 years
  • Male previously treated patients (≥150 Exposure Days) with moderate or severe hemophilia A (i.e. ≤ 5% FVIII:C) who will undergo elective major surgery that is anticipated to require at least 6 consecutive days of daily factor VIII (FVIII) infusions (surgical and post-surgical prophylaxis)
  • Ability to adhere to the protocol requirements

Exclusion Criteria:

  • Hypersensitivity to ReFacto, murine allergen, or hamster allergen 2 History of FVIII inhibitor or current inhibitor, defined as > 0.6 BU
  • Prior participation in this study
  • Any concomitant bleeding disorder other than hemophilia A
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00092976

Locations
United States, California
Los Angeles, California, United States, 90007
United States, New Jersey
New Brunswick, New Jersey, United States, 08903-0019
United States, Ohio
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00092976     History of Changes
Other Study ID Numbers: 3082A2-401
Study First Received: September 28, 2004
Last Updated: December 19, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Hemophilia A

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
 Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013